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510(k) K832479

TRUST RPR CARD TEST #65144 by Emd Chemicals, Inc. — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

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  • K951750 — GLUCOSE TEST ITEM NUMBER 97375/94 (September 6, 1995)
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  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K945322 — PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 (December 7, 1994)
  • K945368 — PHOSPHORUS TEST (PHOS) (December 2, 1994)

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